• Regulatory NewsRegulatory News

    New Bill Would Speed FDA Review of OTC Contraceptives

    Editor's note: This article has been updated to clarify that the Oregon bill allows pharmacists to prescribe certain contraceptive drugs to patients. A new House bill, sponsored by Rep. Mia Love (R-UT), would speed the review of contraceptive drugs by the US Food and Drug Administration (FDA), and includes measures to make the drugs available over-the-counter for adult women. The bill, known as the Over-The-Counter Contraceptives Act , would compel FDA to grant suppl...
  • Regulatory NewsRegulatory News

    EMA Looks to Clarify Import Requirements for Finished Products

    The European Medicines Agency (EMA) is looking to expand its guidance for companies importing finished medicinal products to the EU, in response to increasing globalization and supply chain complexity. Importation Requirements In the EU, companies importing finished medicinal products are required to obtain a manufacturing and importation authorisation (MIA) issued by their local national competent authority. To comply with the regulations, importers must follow good ...